Table 2.
Literature review of the efficacy and safety of coronavirus disease 2019 vaccines in patients with liver disease
|
Ref.
|
Design
|
Vaccine
|
Country/region
|
Number of participants
|
Value
|
Major findings (efficacy)
|
Major findings (safety)
|
| Cirrhosis | |||||||
| John et al[45], 2021 | Multicentre retrospective cohort study | BNT162b2 and mRNA-1273 | United States | Cirrhosis group (n = 20037); Control (n = 20037) | Efficacy | 64.8% decrease in the development of COVID-19 infection after the first dose and a 78.6% decrease after the second dose | NA |
| Thuluvath et al[46], 2021 | Prospective cohort study | BNT162b2, mRNA-1273, and AZD1222 | United States | LT (n = 62); Cirrhosis (n = 79); CLD (n = 92) | Immunogenicity | Antibody was detectable in 82.2% of LT recipients, 96.2% of cirrhosis and 95.7% of CLD without cirrhosis. 61.3% of LT recipients and 24% CLD with/without cirrhosis had poor antibody responses | No patient had any serious AEs |
| Ruether et al[47], 2022 | Prospective cohort study | BNT162b2, mRNA-1273, and AZD1222 | Germany | LT (n = 138); Cirrhosis (n = 48); Control (n = 52) | Immunogenicity | Immunological response rates were 36.6%, 65.4%, and 100% in LT, cirrhosis, and controls, respectively | NA |
| Willuweit et al[48], 2022 | Prospective cohort study | BNT162b2 | Germany | Cirrhosis (n = 166); Control (n = 79) | Immunogenicity | Antibody was detectable in 96% of cirrhosis and 99% of controls. The median SARS-CoV-2 IgG titer was significantly lower in cirrhosis compared to the controls (939 vs 1905 BAU/mL, P = 0.0001) | NA |
| Wang et al[49], 2022 | Multicentre retrospective cohort study | Inactivated vaccine | China | Compensated-cirrhosis (n = 388); Decompensated cirrhosis (n = 165) | Immunogenicity | Antibodies were detectable in 71.6% and 66.1% in compensated-cirrhosis and decompensated-cirrhosis | The vaccines were well tolerated, most AEs were mild and transient |
| Ai et al[50], 2022 | Multicentre prospective cohort study | Inactivated vaccine | China | CLD (n = 284); Compensated cirrhosis (n = 123); Decompensated cirrhosis (n = 30) | Immunogenicity | Antibody detection rates were 76.8% in noncirrhotic CLD group, 78.9% in compensated cirrhotic group, 76.7% in decompensated cirrhotic group, and 90.3% in controls (P = 0.008 vs CLD) | There was no significant difference in AE among subgroups |
| Liver transplant recipients | |||||||
| Rabinowich et al[51], 2021 | Multicentre retrospective cohort study | BNT162b2 mRNA vaccine | Israel | LT patients (n = 80); Control (n = 25) | Immunogenicity | Immunogenicity among LT recipients was significantly lower [47.5% (LT) vs 100% (control), P < 0.001] | No patient had any serious AEs |
| Herrera et al[52], 2021 | Multicentre prospective cohort study | mRNA-1273 | Spain | LT recipients (n = 58) | Immunogenicity | 93% of patients developed immunologic responses to mRNA-1273 vaccine | No serious AEs were reported in LT recipients |
| Strauss et al[53], 2021 | Multicentre retrospective cohort study | BNT162b2 and mRNA-1273 | United States | LT recipients (n = 161) | Immunogenicity | Antibody was detectable in 34% (95%CI: 27%-42%) of participants after first dose, and in 81% (95%CI: 74%-87%) after second dose | NA |
| Nazaruk et al[54], 2021 | Retrospective cohort study | BNT162b2 mRNA vaccine | Poland | LT recipients (n = 65) | Immunogenicity | Antibody detection rate was 88.9% in LT recipients after the second dose | NA |
| Timmermann et al[55], 2021 | Retrospective cohort study | mRNA vaccines | Germany | LT recipients (n = 118) | Immunogenicity | The seroconversion rate was 78.0% in LT recipients. MMF for immunosuppression was risk factors for seronegativity | NA |
| D'Offizi et al[56], 2022 | Retrospective cohort study | BNT162b2 and mRNA-1273 | Italy | LT patients (n = 61); Control (n = 51) | Immunogenicity | Immunological response rates 2 wk after 2nd dose were 47.5% (LT) and 100% (control) (P < 0.001) | NA |
| John et al[57], 2022 | Multicentre retrospective cohort study | BNT162b2 and mRNA-1273 | United States | LT patients (n = 1133); Control (n = 791) | Efficacy | Vaccination with 2 doses of an mRNA vaccine was associated with a 64% decrease in COVID-19 infection and 87% decrease in COVID-19–related death in LT recipients | NA |
| Davidov et al[58], 2022 | Retrospective cohort study | BNT162b2 mRNA vaccine | Israel | LT patients (n = 76); Control (n = 174) | Immunogenicity | Immunological response rates 2 wk after 2nd dose were 72.0% (LT) and 94.2% (control) (P < 0.001) | AEs were reported by 51% LT recipients. No serious events were reported |
| Sakai et al[59], 2022 | Retrospective cohort study | BNT162b2 | Japan | LT patients (n = 56); Control (n = 42) | Immunogenicity | LT recipients showed a lower seroconversion rate (44/56; 78.6%) than healthy controls (41/42; 97.6%) | NA |
| Calleri et al[60], 2022 | Retrospective cohort study | BNT162b2 and mRNA-1273 | Italy | Pre-LT patients (n = 89) | Immunogenicity | In the 89 pre-LT patients, seroconversion rate was 94.4% (23 d after vaccination), and 92.0% (68 d after vaccination) | No serious AEs were reported in participants |
| Viral hepatitis and NAFLD | |||||||
| Xiang et al[61], 2021 | Retrospective cohort study | Inactivated vaccine | China | CHB patients (n = 149) | Immunogenicity | The seroconversion rate was 87.2% in CHB | No serious AEs were reported in participants |
| He et al[62], 2022 | Cross-sectional observational study | Inactivated vaccine | China | CHB patients (n = 362); Control (n = 87) | Immunogenicity | The seroconversion rates of SARS-CoV-2 antibodies were similar between CHB patients and healthy controls | The incidence was similar between CHB patients and controls. No serious AE |
| Wang et al[63], 2021 | Multicentre retrospective cohort study | Inactivated vaccine | China | NAFLD patients (n = 381) | Immunogenicity | The inactivated COVID-19 vaccine was good immunogenicity (95.5%) in patients with NAFLD | AEs within 7 d and within 28 d totaled 95 (24.9%) and 112 (29.4%), respectively. No serious AEs were recorded |
| Autoimmune liver disease | |||||||
| Duengelhoef et al[64], 2022 | Prospective cohort study | BNT162b2, mRNA-1273, and AZD1222 | Germany | AIH (n = 103); PSC (n = 64); PBC (n = 61); Control (n = 95) | Immunogenicity | Seroconversion was measurable in 97% of AIH and 99% of PBC/PSC patients, respectively. In 14% of AIH patients antibody levels were lower compared to PBC/PSC or controls | NA |
| Schneider et al[65], 2022 | Prospective cohort study | BNT162b2 mRNA vaccine | Austria | AIH (n = 12); Control (n = 24) | Immunogenicity | Patients of AIH and healty controls acquired sufficient antibodies after third vaccination | NA |
AE: Adverse event; AIH: Autoimmune hepatitis; CHB: Chronic hepatitis B; CLD: Chronic liver disease; LT: Liver transplant; MMF: Mycophenolate mofetil; NA: Not available; NAFLD: Non-alcoholic fatty liver disease; PBC: Primary biliary cholangitis; PSC: Primary sclerosing cholangitis; CI: Confidence interval.